EARLY, NOT FASTER: DO CONDITIONAL MARKETING AUTHORIZATION SHORTEN TIME TO REIMBURSEMENT IN ITALY?
Author(s)
Stefano Caimi, MSc1, Marika De Nigris, MSc2, Nicola Panzeri, MSc1, Giorgio Casilli, MD2, Dario Lidonnici, BEc, BSc, MSc2, Claudio Jommi, MSc3.
1Roche SpA, Milan, Italy, 2More Than Access (MTA), Milan, Italy, 3Universita del Piemonte Orientale, Milano, Italy.
1Roche SpA, Milan, Italy, 2More Than Access (MTA), Milan, Italy, 3Universita del Piemonte Orientale, Milano, Italy.
OBJECTIVES: This study examines the impact of different European Marketing Authorisations, particularly Conditional (CMA) ones, on national reimbursement timelines. It aims to assess whether accelerated European procedures translate into faster drug access within the Italian NHS.
METHODS: A five-year (2019-2024) retrospective review of 284 centralized approved medicines was conducted using data from the European and Italian Medicines Agencies websites to evaluate time-to-approval (TTA) and time-to-reimbursement (TTR). Subgroup analyses explored differences among medicines undergoing CMA, PRIME, and Accelerated Assessment, as well as those recognized as innovative by AIFA.
RESULTS: Results show median (IQR) TTA of 477 (427-569) days and a TTR of 442 (353-556) days. Medicines under CMA (n=39; 14 per cent) did not show shorter timelines than fully authorized, either at European (489 [433-566] vs 476 [427-558] days) or national (456 [370-586] vs 437 [348-541] days) level. Although medicines under PRIME and Accelerated Assessment gained faster European approvals (386 [294-507] and 294 [283-306] days), these advantages did not shorten reimbursement timings (448 [402-527] and 461 [350-538]). Recognition of innovativeness (n=53; 19 per cent) was not associated with reduced timelines (452 [372-548] and 456 [368-582]).
CONCLUSIONS: In conclusion, while accelerated pathways may fast-track TTA, they rarely translate into faster TTR, highlighting the gap between regulatory intent and market access reality.
METHODS: A five-year (2019-2024) retrospective review of 284 centralized approved medicines was conducted using data from the European and Italian Medicines Agencies websites to evaluate time-to-approval (TTA) and time-to-reimbursement (TTR). Subgroup analyses explored differences among medicines undergoing CMA, PRIME, and Accelerated Assessment, as well as those recognized as innovative by AIFA.
RESULTS: Results show median (IQR) TTA of 477 (427-569) days and a TTR of 442 (353-556) days. Medicines under CMA (n=39; 14 per cent) did not show shorter timelines than fully authorized, either at European (489 [433-566] vs 476 [427-558] days) or national (456 [370-586] vs 437 [348-541] days) level. Although medicines under PRIME and Accelerated Assessment gained faster European approvals (386 [294-507] and 294 [283-306] days), these advantages did not shorten reimbursement timings (448 [402-527] and 461 [350-538]). Recognition of innovativeness (n=53; 19 per cent) was not associated with reduced timelines (452 [372-548] and 456 [368-582]).
CONCLUSIONS: In conclusion, while accelerated pathways may fast-track TTA, they rarely translate into faster TTR, highlighting the gap between regulatory intent and market access reality.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA229
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas